Immunogenicity and Safety of ChulaCov19 BNA159 Vaccine as a Booster Dose in Adults

This clinical trial is designed to assess the safety, tolerability and immunogenicity of a single dose of ChulaCov19 BNA159 vaccine as a booster dose, given at least 3 months after receipt of a previous booster dose of any authorized/approved COVID-19 vaccine.The ChulaCov19 BNA159 vaccine is an messenger ribonucleic acid (mRNA) vaccine. The same vaccine has been evaluated in 192 participants as part of a naïve vaccine trial.

Inclusion Criteria:Must be a male or female aged 18 - 64 (inclusive) at the time of enrolmentMust have completed a primary course of 2 doses of any approved COVID-19 vaccine and 3 months or more have passed since receipt of last booster dose as described in Table 1Must be able to communicate effectively with study personnel and considered reliable, willing, and cooperative in terms of compliance with the protocol requirementsParticipants must sign the written informed consent form prior to undertaking any protocol-related proceduresSARS-CoV-2 rapid antigen test is negative at Day 1 (the day of receiving the study booster dose)Does not intend to receive any other authorized/approved COVID-19 vaccine at the time of enrolment and up to 3 months of the studyMales must be surgically sterile (>30 days since vasectomy with no viable sperm), practice true abstinence or, if engaged in sexual relations with a female of child-bearing potential, the participants and their partner must use an acceptable, highly effective, double-barrier contraceptive method* from Screening and for a period of at least 60 days after vaccinationA female participant is eligible if she is not pregnant, or breastfeeding indicated by one of the following conditions:With childbearing potential: she agrees to use an effective contraceptive method or abstinence from at least 4 weeks prior to the study intervention administration until at least 12 weeks after the study intervention administration, orWith non-childbearing potential. To be considered of non-childbearing potential, a female must be post-menopausal for at least 1 year or surgically sterileParticipants must be in general good health* based on medical history and physical examination, as determined by the PI at Screening.Participants must agree to refrain from donating blood, plasma, ova, sperm, or organs during the whole study.Exclusion Criteria:History of a systemic hypersensitivity or life-threatening reaction to a vaccine containing any of the same or similar substances.History of test-confirmed by PCR or rapid antigen test to SARS-CoV-2 COVID-19 infection within 3 months prior to randomisation.Presence of clinically significant medical history*, unstable chronic or acute disease that, in the opinion of the PI, may increase the risk of exposure to the investigational vaccineHistory of having any significant side effects after receipt of any other COVID-19 vaccine eg. endocarditis, pericarditis or myocarditis. History of any severe reactogenic side effects or other medical illness that were thought to be associated with vaccine.Presence of an acute illness* or with fever at 38.00 C or more within 72 hours prior to vaccination.Bleeding disorders or taking an anticoagulant or anti-platelet agent that may contraindicate for intramuscular injection based on Investigator's judgmentInadequate venous access to allow the collection of blood samples.Received any prophylactic or therapeutic vaccine, biologic product, device or blood product, within 4 weeks of vaccination or 5 half-lives (whichever is longer) or anticipate doing so in the follow-up period defined for this study. For influenza vaccine, however, can be administered up to 14 days prior to randomization.History of ever had an anaphylaxis reaction to food, medication, or vaccination.Participant is immunosuppressed as caused by disease or immunosuppressive therapy or anticipated need to use of any chemotherapy or immunosuppressive agents* within the next 6 months.Participation in any of the other investigational trials of vaccines, therapeutic, or medical devices 12 weeks before or during the 6 months of this study.Received immunoglobulins and/or any blood or blood products within 3 months before vaccination day or plans to receive any blood or blood products at any time during the study.